圣湘生物(688289.SH)产品取得医疗器械注册证

Core Viewpoint - Shengxiang Bio (688289.SH) has received a Medical Device Registration Certificate from the National Medical Products Administration for its nucleic acid test kits for human coronavirus, parainfluenza virus, and novel coronavirus, indicating a significant advancement in its product offerings [1] Group 1: Product Features - The newly certified nucleic acid test kits utilize multiplex fluorescent PCR technology, offering high sensitivity, high specificity, and ease of operation [1] - The tests can accurately identify three pathogens in as little as 30 minutes, enhancing diagnostic efficiency [1] Group 2: Application and Market Relevance - The product can be integrated with the company's existing rapid detection solutions for respiratory infections, allowing for unified sampling and amplification [1] - This series of products covers common respiratory viruses, bacteria, fungi, atypical pathogens, and drug-resistant genes, making it suitable for outpatient, emergency, and inpatient settings [1] - The tests support flexible combinations based on clinical presentation, regional, and seasonal epidemiological characteristics, effectively addressing complex situations such as co-circulation of multiple pathogens and mixed infections [1]